ipsc-cms combined with lvad or cabg for the treatment of heart failure

Conditions: Heart Failure; Heart Failure At NYHA Stage III or IV

Summary: this clinical trial investigates the safety, feasibility, and therapeutic potential of a combined approach using hicm-188 cardiomyocyte injection delivered intramyocardially alongside either lvad implantation or cabg surgery in patients with advanced ischemic heart failure.


Eligibility criteria:
inclusion criteria: * male or female aged 35-75 years (inclusive) at the time of signing the informed consent form. * capable of understanding the informed consent form, voluntarily agreeing to participate in the trial, and signing the informed consent form. * diagnosed with end-stage heart failure. * receiving optimized medical therapy for heart failure, with new york heart association (nyha) functional class iii-iv. * echocardiography demonstrating regional hypokinesia or akinesia of the ventricular wall. * cardiac magnetic resonance imaging (mri) confirming left ventricular ejection fraction (lvef) ≤35%. * myocardial perfusion-metabolism imaging with radionuclide indicating infarcted myocardium in the left anterior descending (lad) artery territory. * meets criteria for coronary artery bypass grafting (cabg) under cardiopulmonary bypass during screening and requires cabg surgery. * for patients enrolled in the lvad implantation group, the following additional criteria must be met: 1. definitive indication for lvad implantation due to end-stage heart failure. 2. anticipated significant improvement in hemodynamic stability post-lvad implantation, with potential for further cardiac functional improvement via myocardial cell injection. 3. absence of significant contraindications for lvad surgery. exclusion criteria: * history of pacemaker, implantable cardioverter-defibrillator (icd), or cardiac resynchronization therapy (crt). * severe valvular heart disease. * acute myocardial infarction or history of percutaneous coronary intervention (pci) within 1 month prior to screening. * non-ischemic cardiomyopathy or acute viral myocarditis. * acute cerebrovascular event within 1 month prior to screening. * history of malignancy within 5 years prior to screening. * autoimmune disease or chronic use of immunosuppressive agents. * history of organ transplantation. * planned concurrent major surgery (excluding left ventricular aneurysm resection or left atrial appendage closure/resection). * malignant ventricular arrhythmia. * contraindications for cabg surgery. * positive serology for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), hepatitis c virus (hcv) antibody, or treponema pallidum antibody. * inability to undergo cardiac mri or pet/ct imaging. * contraindications to immunosuppressive therapy or inability to comply with the protocol-specified immunosuppressive regimen. * hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, tacrolimus, macrolides, prednisone acetate/methylprednisolone, other corticosteroids, or basiliximab. * participation in another clinical trial within 3 months prior to screening. * pregnancy, lactation, or positive pregnancy test in female patients. * any other condition deemed by the investigator to render the patient unsuitable for trial participation.

Keywords: lvad cabg ipsc-cms